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Glossary of terms

Allogeneic stem cell

"AL-oh-jin-AY-ik"

Refers to healthy blood-forming cells (stem cells) that have come from a suitably matched donor

Bilirubin

"BIH-lih-ROO-bin"

A yellow pigment in bile that is produced by the breakdown of red blood cells. A healthy liver removes most of the bilirubin from your body through the bile ducts. If the liver or bile ducts are damaged, bilirubin can enter the bloodstream and cause yellowing of the skin or eyes (called jaundice)

Bone marrow

"bown mah·row"

The soft, spongy tissue found in the center of most bones. There are 2 types of bone marrow: red and yellow. Red bone marrow gives rise to the stem cells that become red blood cells, white blood cells, and platelets. Yellow bone marrow contains stem cells that become cells for cartilage, fat, or bone

Conventional T cell (Tcon)

"Con-VEN-shuh-nul Tee sell (Tee con)"

A type of T cell and main force behind your body’s infection- and cancer-fighting immune response. It turns on and directs other cells in the immune response. Also called fighter cells

Creatinine

"kree-A-tih-neen"

A normal waste product made from the muscle tissue in your body. It is normally removed from your body by the kidneys. If levels build up in your blood, it may be a sign of kidney disease

Engraftment

"en-GRAFT-ment"

Process in which transplanted stem cells travel through the blood to the bone marrow, where they begin to make new white blood cells, red blood cells, and platelets. This happens within 2 to 4 weeks after a stem cell transplant

Graft-versus-host disease (GVHD)

"graft-vers-us-host diz-ease"

A condition that occurs when donated stem cells or bone marrow (the graft) sees the healthy tissues in the recipient’s body (the host) as foreign and attacks them. The signs and symptoms may be mild to severe and life-threatening. May happen within the first few months after transplant (acute) or much later (chronic)

Hematopoietic stem and progenitor cell (HSPC)

"heh-ma-tuh-poy-EE-tik stem and prow·jeh·nuh·tor sell"

A group of cells with the ability to self-renew and differentiate into specific types of cells, including blood cells

Hemoglobin

"HEE-moh-GLOH-bin"

An iron protein in red blood cells that transports oxygen from the lungs to tissues and organs throughout the body

Immunosuppressant

"imm-you-no-sue-press-ant"

A medication that lowers the body’s immune response and makes it hard for the body to fight infection or other diseases, including cancer. May be used to help keep a person from rejecting a transplant

Immunotherapy

"imm-u-NO-ther-a-pee"

A type of treatment that uses substances to activate or suppress the immune system to help the body fight cancer, infection, and other diseases. Some of these medications may target specific cells in the immune system, while others may act in a more general way

Methotrexate

"meth-o·trek·sayt"

A type of chemotherapy that helps kill cancer cells

Mucosal

"myoo-KOH-sall"

Refers to the soft tissue that lines the body’s canals and organs in the digestive, respiratory, and reproductive systems. Also called the mucous membrane and plays an important part in immunity

Neutrophil

"NOO-troh-fill"

A type of white blood cell that plays a key role in helping your body fight infection

Platelet

"PLAYT-let"

A small piece of cell that helps your body form clots to stop bleeding

Regulatory T cell (Treg)

"reg-u·luh·tory Tee sell (Tee reg)"

A type of T cell that reduces the activity of other T cells once an infection- or disease-causing threat has been eliminated from the body. Can also help prevent the T cells from attacking healthy cells in the body. Also called suppressor cells

Stem cell

"stem sell"

A cell that gives rise to other types of cells, such as blood cells

T cell

"T sell"

A type of white blood cell. Also called lymphocytes; plays an important role in helping the immune system fight germs and protect the body from disease

Tacrolimus

"tack-roh-lih-mus"

Medication used to help lower the risk of infection, GVHD, and other complications that may happen when immune system activity is suppressed, such as with chemotherapy

IMPORTANT SAFETY INFORMATION AND INDICATION

ISI tray

ISI tray

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

IMPORTANT SAFETY INFORMATION

Before you receive TREGZI, tell your healthcare provider about all your medical conditions, including if you have:

  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TREGZI can cause serious side effects, including:

  • Graft Failure. Failure to rebuild the blood and/or immune system, which may be fatal, can occur after receiving TREGZI. Your healthcare provider will monitor you closely after TREGZI administration.

  • Graft-Versus-Host Disease (GVHD). Immune reactions from the donor’s cells may occur soon (days) or long (months) after receiving TREGZI. Tell your healthcare provider right away about any signs and symptoms including rash, joint pain, diarrhea, or yellowing of the eyes.
  • Infusion Reactions. Infusion reactions can occur after TREGZI infusion. Tell your healthcare provider right away about any signs and symptoms including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness.
  • Secondary Cancer and Cancer from Donor Cells. New cancers can develop after treatment with TREGZI. If you are diagnosed with a new cancer after treatment, contact Orca Bio at 1-877-290-6722.
  • Transfer of Serious Infections. Transfer of serious infectious diseases can occur because TREGZI is made from the human blood cells of a donor. Transfer may occur even though donors are screened and tested for infectious diseases.

The most common side effects of TREGZI include inflammation of the digestive tract, diarrhea, rash, viral infections, infections from an unknown pathogen, abdominal pain, vomiting, nausea, bacterial infections, bleeding, acute graft-versus-host disease (aGVHD), swelling and fungal infections.

These are not all the possible side effects of TREGZI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

Please see accompanying full Prescribing Information including Patient Information.